BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2241394 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06681
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012 - DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED EVIDENCE OF POWER ON RESETS ON (B)(6) 2012. ON EXAMINATION, THE BATTERY CAP RETURNED WITH THE PUMP WAS FREE OF PHYSICAL DAMAGE, AS WAS THE PUMP'S BATTERY COMPARTMENT. ON TESTING, THE PUMP POWERED ON NORMALLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF MOISTURE OR DEFECT OF THE PUMP'S INTERIOR. INVESTIGATION WAS NOT ABLE TO DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THREE DAYS AGO SHE WOKE UP AND THERE WAS NO POWER TO HER PUMP. SHE CHANGED HER BATTERY AND HER PUMP BEGAN WORKING FINE. SHE CHANGED HER BATTERY AND THE PUMP THEN FUNCTIONED PROPERLY. PRIOR TO HER PUMP POWERING OFF SHE SAID SHE RECEIVED NO LOW BATTERY OR REPLACE BATTERY WARNING. THE BATTERY CAP WAS INTACT. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR